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FDA issues warning on propofol (Diprivan), (April 25, 2001)


The US Food and Drug Administration (FDA) has issued a warning against the off-label use of the injectable sedative propofol in pediatric patients in intensive care units.

Propofol is used for induction and maintenance of anesthesia. Because it causes minimal respiratory depression, with easy arousability and recovery taking place within a few minutes after the infusion has been stopped, it is also used in intensive care units, emergency rooms and in other areas for sedation during minor procedures and during intubation and artificial ventilation. Although general anesthesia is the only approved pediatric use for the drug, its attractive characteristics have led some physicians to use it in children in intensive and emergency care settings.

The FDA became concerned after reviewing data from a randomized, controlled clinical trial of the safety and effectiveness of propofol vs. standard sedative agents in pediatric intensive care units. About 10% of children who received propofol died, compared with only 4% of children receiving standard sedating agents. Further trials are under way. CMAJ is committed to releasing FDA and Health Canada drug warnings as soon as they are available .

 

 

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